Events

Retiro De Equipo (Recall) de Ethicon HARMONIC ACE+ 7 Laparoscopic Shears

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00994-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00994-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has determined that under extreme handling circumstances, damage, such as a hole, can occur in the tyvek lid due to an interaction between the advanced haemostasis button and tyvek, which would could compromise device sterility. the manufacturer has received no reports of adverse events for this issue.
  • Acción
    Johnson & Johnson Medical are advising users of alternative products to use. Users are advised to inspect stock and quarantine any affected product to be returned to Johnson & Johnson. This action has been closed-out on 05/12/2016.

Device

Ethicon HARMONIC ACE+ 7 Laparoscopic Shears
  • Modelo / Serial
    Ethicon HARMONIC ACE+ 7 Laparoscopic Shears Product Codes: HARH23, HARH231, HARH36, HARH361, HARH45 and HARH451Batches with expiration dates before 08-2020ARTG Number: 118011
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd